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FDA 510(k)

CK-MB (NAC-ACT)

K-Number: K951223 · 1995-12-26

ApplicantRandox Laboratories, Ltd.
Decision Date1995-12-26
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB (NAC-ACT) is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1995-12-26 under 510(k) number K951223. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-MB (NAC-ACT)?

CK-MB (NAC-ACT) is a medical device that received FDA 510(k) clearance on 1995-12-26. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K951223.

When did CK-MB (NAC-ACT) receive FDA 510(k) clearance?

CK-MB (NAC-ACT) received FDA 510(k) clearance on 1995-12-26, under 510(k) number K951223.

Who is the listed applicant for CK-MB (NAC-ACT)?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CK-MB (NAC-ACT)?

The FDA product code for CK-MB (NAC-ACT) is CGS.

Other records listing Randox Laboratories, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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Related Devices (Code: CGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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